吉西他滨的固定速率输注与标准速率输注治疗晚期恶性肿瘤疗效及安全性的Meta分析  

Fixed-dose rate infusion and standard rate infusion of gemcitabine in patients with advanced cancer: a Meta-analysis of seven trials

作　　者：赵佳[1] 曲秀娟[1] 李智[1] 宋娜[1] 郭晓玉[1] 刘云鹏[1] 

机构地区：[1]中国医科大学附属第一医院,辽宁沈阳110122

出　　处：《沈阳药科大学学报》2015年第6期475-483,共9页Journal of Shenyang Pharmaceutical University

摘　　要：目的比较吉西他滨以固定速率(fixed-dose rate infusion,FDR)输注与标准速率输注治疗晚期恶性肿瘤患者的有效性及安全性。方法检索Medline、Embase及Cochran Library数据库,筛选以吉西他滨FDR化疗组为试验组、标准30 min输注(stand infusion,SI)化疗组为对照组治疗晚期恶性肿瘤的随机对照临床试验(randomized controlled trial,RCT)。由2位评价者分别收集资料,严格依据纳排标准筛选文献。结果从259篇文献中筛选出符合纳入标准的7篇文献,共1 314例患者,其中FDR组655例,SI组659例。两组间总生存时间(overall survival,OS)、总反应率(overall response rate,ORR)无统计学意义,HR=0.94,95%CI(0.83,1.07),P=0.343;RR=0.99,95%CI(0.79,1.24),P=0.918;FDR组1年生存率(1-year survival rate,1-year SR)优于SI组,RR=1.42,95%CI(1.03,1.43),P=0.02;在血液学相关不良反应中,FDR组3/4度白细胞减少发生率明显增加,RR=1.95,95%CI(1.47,2.61),P<0.001;中性粒细胞的减少发生率明显增加,RR=1.93,95%CI(1.5,2.5),P<0.001;贫血明显增加,RR=1.58,95%CI(1.12,2.22),P<0.001;血小板减少发生率在两组间无统计学意义,RR=1.67,95%CI(0.89,3.1),P=0.11;非血液学相关不良反应中两组间无统计学意义,RR=1.28,95%CI(0.88,1.85),P=0.197。结论吉西他滨治疗晚期恶性肿瘤FDR组与SI组的OS及ORR均无差异,虽然FDR组1-year SR高于SI组,但血液学相关不良反应也明显增高。现有证据不足以推荐吉西他滨的FDR输注方式应用于临床。Objective To compare fixed dose rate infusion and standard infusion of gemcitabine with in patients with advanced cancer patients on efficacy and safety. Methods Electronic databases of MEDLINE were searched using key words of ‘cancer＇,‘gemcitabine＇,‘fixed dose rate＇,and their alternative spellings,screening randomized controlled clinical trials（ RCT） with fixed dose rate infusion（ 10 mg·m- 2·min- 1,FDR） of gemcitabine for the experimental group,the standard 30 minutes infusion（ SI） for the control group. Results Seven RCTs were selected from 259 articles,a total of 1 314 patients were enrolled,of which655 cases in FDR group,659 cases in SI group. There was no significant difference on overall survival（ OS）between the FDR group and the SI group HR = 0. 94,95% CI（ 0. 83,1. 07）,P = 0. 343; 1-year survival rate（ 1-year SR） of FDR group was higher compared with SI group,RR = 1. 42,95% CI（ 1. 0,1. 43）,P = 0. 02;Overall response rate（ ORR） of FDR group had no significant difference with SI group,RR = 0. 99,95% CI（0. 79,1. 24）,P = 0. 918; In FDR group,more 3 /4grade hematological toxicities including Leukocytopenia,neutropenia,anemia than SI group,RR = 1. 95,95% CI（ 1. 47,2. 61）,P〈0. 001; RR = 1. 93,95% CI（ 1. 5,2. 5）,P〈0. 001; RR = 1. 58,95% CI（ 1. 12,2. 22）,P〈0. 001,however no difference with SI group on thrombocytopenia,RR = 1. 67,95% CI（ 0. 89,3. 1）,P = 0. 11; No significant difference in nausea / vomiting was observed between the two groups,RR = 1. 28,95% CI（ 0. 88,1. 85）,P = 0. 197. Conclusions FDR group had no difference with SI group on OS and ORR,and patients received FDR had higher 1-year SR but experienced more grade 3 /4 hematological（ neutropenia,leukopenia and anemia） then patients received SI.

关 键 词：恶性肿瘤 吉西他滨 固定速率 META分析 

分 类 号：R730.53[医药卫生—肿瘤] R971[医药卫生—临床医学]